The European Commission has granted approval for the use of nivolumab to treat patients with the most common forms of advanced lung and advanced kidney cancer.

This significantly broadens the current label for nivolumab to include the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy, in addition to adult patients with advanced renal cell carcinoma (RCC) who have received prior therapy. 

Nivolumab, a PD-1 inhibitor, was previously designated a Promising Innovative Medicine in both indications by the UK Medicines and Healthcare Products Regulatory Agency.

This approval expands nivolumab’s existing lung cancer indication so it can now be used to treat both metastatic squamous NSCLC and non-squamous NSCLC patient populations, which together represent 85% of lung cancer cases, as well as kidney cancer. 

In 2013, around 45,500 people were diagnosed with lung cancer and over 35,000 deaths were attributable to the disease in 2012, which is more than breast cancer and bowel cancer deaths combined.

For patients with advanced disease, long-term survival is poor with only 5 in 100 people surviving beyond five years.

In the same time period, over 11,000 people were diagnosed with kidney cancer and in 2012, around 4,300 people died from the disease.

In cases of late-stage kidney cancer, it is estimated that less than 10% of patients will survive for five years of more in the UK.

Commenting on the implications for advanced lung cancer patients, Professor Dean Fennell, Chair of Thoracic Medical Oncology, University of Leicester, said, “The survival outlook for patients with this cancer is very poor once the disease has spread. Until today, chemotherapy has been the main option, offering limited benefits and significant side effects. The launch of nivolumab will irrevocably change the treatment of this condition and represents one of the biggest advances in almost two decades. Treating these patients as quickly as possible is vital so we hope access will be as prompt as possible across the UK.”

Commenting on the impact of this decision for kidney cancer patients, Dr. Samra Turajlic, Consultant Medical Oncologist, The Royal Marsden, commented, “In the UK, the incidence of kidney cancer has more than doubled over the last 30 years and the outlook for patients with advanced stages of this disease can be very poor, with few patients surviving beyond five years. A particular area of unmet clinical need are those patients whose cancer has become resistant to standard first or second line therapy with VEGF inhibitors. In this setting, nivolumab is the first immunotherapy to demonstrate in a clinical trial, significant improvement in kidney cancer survival compared to standard therapy, whilst causing fewer side effects.”

Source: Bristol Meyers Squibb